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Regulatory Affairs Director

2 weeks ago

Pretoria, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time

MNA Recruitment (Pty) Ltd is seeking a highly experienced Regulatory Affairs Manager to join their team.

This role involves managing work streams for assigned portfolios, assisting with internal product queries from relevant departments, and ensuring the maintenance and/or update of existing registrations in accordance with relevant legislation, regulations and guidelines.

Responsibilities include:

  • Co-ordinating and submitting new product applications in South Africa and other applicable territories
  • Maintaining current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
  • Establishing effective relationships with Regulatory Authorities, internal and external stakeholders

The ideal candidate will have experience in the use of CTD software builder and compilation of eCTD applications, management of personnel resources, ability to prioritise and work to tight deadlines, systems and operations analysis, basic cost management skills, active learning, strategic thinking, ability to cope with a high degree of complexity and change, cross-functional skills, ability to set standards and objectives and monitor progress, complex problem-solving and decision-making skills, customer relationships, development of people, and responsibility, excellence and collaboration.

Qualifications include a Bachelor's degree in Pharmacy or Diploma in Pharmacy and Registration with the South African Pharmacy Council, minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines, demonstrable experience across the product development, commercialization and maintenance lifecycle, sound project management capabilities, and proven ability to consistently deliver quality, time and cost standards.